Data / Medical devices / United States / Cork Medical, LLC
Cork Medical, LLC: FDA-registered device maker in Indianapolis, IN, United States, 5 510(k) clearances
Cork Medical, LLC is registered with the FDA (registration 3010588638) in Indianapolis, IN, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010588638
- Address
- 8000 Castleway Drive, Indianapolis, IN, United States, 46250
- Owner or operator
- Cork Medical Products, LLC (10046132)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 6, 2014
- Registered through
- 2026
- Brand names listed
- Cork Medical, LLC, Elite Balance Air, Forever Cushion, Nisus, Nisus ONE Negative Pressure Wound Therapy System, VERSA Negative Pressure Wound Therapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cushion, Flotation | KIC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 27, 2025 | K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | OMP | Substantially Equivalent | Cork Medical | accessdata.fda.gov |
| August 21, 2024 | K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | OMP | Substantially Equivalent | Cork Medical | accessdata.fda.gov |
| August 13, 2021 | K203693 | Nisus Touch Negative Pressure Wound Therapy Pump | OMP | Substantially Equivalent | Cork Medical Products, LLC | accessdata.fda.gov |
| October 24, 2014 | K140022 | NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT | OMP | Substantially Equivalent | Cork Medical Products, LLC | accessdata.fda.gov |
| May 2, 2014 | K132004 | NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE | OMP | Substantially Equivalent | Creo Quality, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Cushion, Flotation
- All makers of Mattress, Air Flotation, Alternating Pressure
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
Updated June 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.